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Venetoclax Shows Low Therapeutic Activity in BCL2-Positive Relapsed/Refractory Peripheral T-Cell Lymphoma: A Phase 2 Study of the Fondazione Italiana Linfomi.


ABSTRACT: Patients with relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) have a poor prognosis, with an expected survival of less than 1 year using standard salvage therapies. Recent advances in our understanding of the biology of PTCL have led to identifying B-Cell Lymphoma 2 (BCL2) protein as a potential therapeutic target. BLC2 inhibitor venetoclax was investigated in a prospective phase II trial in patients with BCL2-positive R/R PTCL after at least one previous standard line of treatment (NCT03552692). Venetoclax given alone at a dosage of 800 mg/day resulted in one complete response (CR) and two stable diseases (SDs) among 17 enrolled patients. The majority of patients (88.2%) interrupted the treatment due to disease progression. No relationship with BCL2 expression was documented. At a median follow-up of 8 months, two patients are currently still on treatment (one CR and one SD). No case of tumor lysis syndrome was registered. Therefore, venetoclax monotherapy shows activity in a minority of patients whose biological characteristics have not yet been identified.

Clinical trial registration

www.clinicaltrials.gov (NCT03552692, EudraCT number 2017-004630-29).

SUBMITTER: Ballotta L 

PROVIDER: S-EPMC8685372 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Venetoclax Shows Low Therapeutic Activity in BCL2-Positive Relapsed/Refractory Peripheral T-Cell Lymphoma: A Phase 2 Study of the Fondazione Italiana Linfomi.

Ballotta Laura L   Zinzani Pier Luigi PL   Pileri Stefano S   Bruna Riccardo R   Tani Monica M   Casadei Beatrice B   Tabanelli Valentina V   Volpetti Stefano S   Luminari Stefano S   Corradini Paolo P   Lucchini Elisa E   Tisi Maria Chiara MC   Merli Michele M   Re Alessandro A   Varettoni Marzia M   Pesce Emanuela Anna EA   Zaja Francesco F  

Frontiers in oncology 20211206


Patients with relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) have a poor prognosis, with an expected survival of less than 1 year using standard salvage therapies. Recent advances in our understanding of the biology of PTCL have led to identifying B-Cell Lymphoma 2 (BCL2) protein as a potential therapeutic target. BLC2 inhibitor venetoclax was investigated in a prospective phase II trial in patients with BCL2-positive R/R PTCL after at least one previous standard line of treatment (  ...[more]

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